An FDA advisory panel supported an FDA proposal calling for larger clinical trials of pulse oximeters to improve their accuracy in people with darker skin tones.
Manufacturers may need to study pulse oximeters across the full spectrum of human skin if the US Food and Drug Administration puts a proposed clinical trial approach into action.
The plan, discussed at an advisory committee meeting on 2 February, addresses persistent problems with the accuracy of pulse oximeters...
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.
